Page 4 - Introduction QC

P. 4

GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com

(a) The establishment of any specifications, standards, sampling plans, test
procedures, or other laboratory control mechanisms required by this subpart,
including any change in such specifications, standards, sampling plans, test
procedures, or other laboratory control mechanisms, shall be drafted by the
appropriate organizational unit and reviewed and approved by the quality control
unit.

(b) Laboratory controls shall include the establishment of scientifically sound
and appropriate specifications, standards, sampling plans, and test procedures
designed to assure that components, drug product containers, closures, in-
process materials, labeling, and drug products conform to appropriate standards
of identity, strength, quality, and purity.

International GMPs

Chapter 1 Quality Management

1.3 Quality Control is that part of Good Manufacturing Practice which is
concerned with sampling, specifications and testing, and with the organization,
documentation and release procedures which ensure that the necessary and
relevant tests are actually carried out and that materials are not released for use,
nor products released for sale or supply, until their quality has been judged to
be satisfactory.

Overview

The QC laboratory must have o quality system in place. The primary objective of

the quality system is to assure the accuracy and precision of laboratory results
so that they will be Reliable, Interpretable, Repeatable and Defensible.

This module is based upon the guidance within GMP rules and ISO 17025 -
General requirements for the competence of testing and calibration laboratories.
ISO 17025 can be used by laboratories as a standard to develop and establish a
quality system, and for the assessment by their clients or by third parties. The
standard is also being used as a criterion for laboratory accreditation, but is not

1 2 3 4 5 6 7 8 9